N/A
Completed N=32
Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
Source: ClinicalTrials.gov NCT02246777 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Mean Intraocular Pressure (IOP) — 9.4; 9.5; 10.0 mmHG
Summary
The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure (IOP) |
9.4; 9.5; 10.0 | — |
| PRIMARY Change From Baseline in IOP |
-5.4; -5.4; -4.9 | — |
| PRIMARY Percent Change From Baseline in IOP |
-35.4; -33.7; -31.1 | — |
| PRIMARY Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 |
72.4; 82.1; 61.5 | — |
| PRIMARY Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP |
0.0; 0.0; 3.2 | — |
| PRIMARY Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP |
88; 12; 0; 0; 0; 94 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of normal tension glaucoma.
- Indicated for filtration surgery using Ex-PRESS®.
- Understand and provide Informed Consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Women who are pregnant, lactating, or planning to be pregnant during the study period.
- Diagnosis of angle closure glaucoma or secondary glaucoma.
- History of glaucoma surgery.
- Ophthalmologic surgery within the past 6 months.
- Difficulty with applanation tonometry measurement.
- Corneal dystrophy.
- Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
- Severe blepharitis or dry eye.
- History of metal allergy.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02246777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.